Prevents pregnancy for up to 8 years. Sold as Norplant, Norplant System In Plastic Container, Jadelle, Levonorgestrel, Plan B and 5 more. Every FDA application for this active ingredient: 10 branded and 21 generic.
As of Nov 13, 2026, FDA lists 31 applications for Levonorgestrel (sold as Norplant, Norplant System In Plastic Container, Jadelle and others), first approved Dec 10, 1990, with 16 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Mirena | Part D | $745K | -2% | 630 |
| Liletta | Part D | $183K | +519% | 202 |
| Kyleena | Part D | $50K | +16% | 43 |
| Skyla | Part D | $18K | +53% | 18 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 10, 1990 | NorplantNDA 19897 · New dosage form | Population Council | 11 | Discontinued |
| Dec 10, 1990 | Norplant System In Plastic ContainerNDA 20088 · New dosage form | Wyeth Pharms Inc | 13 | Discontinued |
| Aug 15, 1996 | LevonorgestrelNDA 20627 · New dosage form | Wyeth Pharms Inc | 0 | Discontinued |
| Nov 1, 1996 | JadelleNDA 20544 · New dosage form | Population Council | 4 | Discontinued |
| Jul 28, 1999 | Plan BNDA 21045 · TYPE 3/4 | Fdn Consumer | 13 | Discontinued |
| Dec 6, 2000 | MirenaNDA 21225 · New dosage form | Bayer Hlthcare | 26 | Marketed |
| Jun 24, 2009 | LevonorgestrelANDA 78666 | Watson Labs | 0 | Discontinued |
| Jul 10, 2009 | Plan B One-StepNDA 21998 · New dosage form | Fdn Consumer | 5 | Marketed |
| Aug 28, 2009 | LevonorgestrelANDA 78665 | Fdn Consumer | 2 | Discontinued |
| Dec 30, 2010 | LevonorgestrelANDA 90740 | L Perrigo Co | 0 | Discontinued |
| Jul 12, 2012 | LevonorgestrelANDA 200670 | Fdn Consumer | 2 | Discontinued |
| Jan 9, 2013 | SkylaNDA 203159 · New formulation or manufacturer | Bayer Hlthcare | 11 | Marketed |
| Jan 23, 2013 | LevonorgestrelANDA 91328 | Lupin Ltd | 0 | Marketed |
| Feb 22, 2013 | LevonorgestrelANDA 202508 | Novel Labs Inc | 3 | Marketed |
| Jun 19, 2014 | Fallback SoloANDA 201446 | Lupin | 4 | Marketed |
| Aug 20, 2014 | LevonorgestrelANDA 202334 | Perrigo R And D | 3 | Marketed |
| Sep 11, 2014 | Opcicon One-StepANDA 202635 | Sun Pharm | 1 | Marketed |
| Oct 31, 2014 | LevonorgestrelANDA 202739 | Xiromed | 3 | Marketed |
| Feb 26, 2015 | LilettaNDA 206229 · New formulation or manufacturer | Medicines360 | 9 | Marketed |
| May 29, 2015 | LevonorgestrelANDA 202380 | Naari Pte | 2 | Marketed |
| Jun 5, 2015 | LevonorgestrelANDA 202246 | Alvogen | 3 | Discontinued |
| Dec 8, 2015 | Athentia NextANDA 206867 | Aurobindo Pharma | 3 | Marketed |
| Mar 11, 2016 | Her StyleANDA 207976 | Novast Labs | 3 | Marketed |
| Mar 25, 2016 | LevonorgestrelANDA 207044 | Glenmark Pharms Ltd | 3 | Marketed |
| Sep 2, 2016 | LevonorgestrelANDA 202684 | Lotus Pharm Co Ltd | 0 | Discontinued |
| Sep 2, 2016 | LevonorgestrelANDA 202740 | Xiromed | 0 | Discontinued |
| Sep 16, 2016 | KyleenaNDA 208224 · New formulation or manufacturer | Bayer Hlthcare | 4 | Marketed |
| Jul 3, 2018 | LevonorgestrelANDA 204044 | Laboratoire Hra | 0 | Marketed |
| Sep 18, 2018 | LevonorgestrelANDA 205329 | Xiromed | 0 | Marketed |
| May 2, 2019 | LevonorgestrelANDA 207660 | Naari Pte | 0 | Marketed |
| Sep 30, 2025 | LevonorgestrelANDA 219102 | Annora Pharma | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Lupin
Aurobindo Pharma